Catheter system

Abstract

The utility model relates to a catheter system. A catheter system includes a catheter and a system module. The catheter includes a catheter tube configured for placement in a patient; and a lumen wall defining a lumen extending along the catheter tube between the bushing and the distal tip. A system module is coupled with the catheter and includes a first electrode and a second electrode disposed within the lumen for determining an electrical impedance between the first electrode and the second electrode, where the first electrode and the second electrode are coupled with the lumen wall adjacent the distal tip and the second electrode is spaced apart from the first electrode. The system module is configured for placement within a patient.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. patent application No. 18 / 119,239, filed on March 8, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to catheter systems. Background Art

[0004] Thrombosis, biofilm accumulation, and bacterial adhesion within the lumen of long-term vascular catheters can lead to reduced catheter function and catheter replacement, which imposes significant costs and risks on patients. Current clinical practice can detect thrombosis that may originate from or involve catheter-related medical devices through various imaging and contrast modalities (such as contrast venography, duplex ultrasound, etc.). However, these methods do not directly assess thrombi within the catheter and cannot be assessed without complete removal of the device.

[0005] The catheter care team and nurses can assess the presence of intra-catheter thrombi during routine maintenance and administration, for example, by presenting reduced device functionality, such as pressure buildup or clogging. This can lead to clinical judgment and intervention, such as administration of anticoagulants, e.g., low-dose warfarin or low molecular weight heparin. However, typical thrombosis must not occur until late in the process to directly affect the flow rate and injection functionality in the catheter-related device.

[0006] Central line-associated bloodstream infections (CLABSI) and catheter-related bloodstream infections (CRBSI) can be difficult to identify, diagnose, and treat. A large program of external laboratory testing and bacterial culture is required, which can take an extended amount of time and lead to prolonged hospital stays. Clinical administration of antibiotics can acutely treat blood-related infections, but if the infection originates from the device, this can re-cultivate, proliferate, and lead to reinfection. This can lead to poor clinical outcomes, patient re-entry to the hospital, etc. In addition, hospitals pay huge fines for CLABSI-positive cases, which are confirmed by laboratory tests in which the ends of the removed devices are cut and cultured in the laboratory assay.

[0007] Disclosed herein are systems and methods that address the aforementioned problems. Utility Model Content

[0008] According to some embodiments, a catheter system is disclosed herein, comprising a catheter having a catheter tube configured to be placed in a patient, wherein the catheter tube comprises an inner cavity wall, and the inner cavity wall defines an inner cavity extending along the catheter tube between a sleeve and a distal end. The catheter system also includes a system module coupled to the catheter tube. The system module comprises a first electrode and a second electrode arranged in the inner cavity, for determining an electrical impedance between the first electrode and the second electrode, wherein the first electrode and the second electrode are coupled to the inner cavity wall adjacent to the distal end, and wherein the second electrode is spaced apart from the first electrode. The system module is configured to be placed in the patient during use.

[0009] In some embodiments, the system module includes a console configured to provide a notification when the determined electrical impedance exceeds an impedance limit.

[0010] In some embodiments, the system module may further include a console coupled to the first electrode and the second electrode. The console may include a processor and a memory having logic stored thereon. The logic, when executed by the processor, performs an operation, the operation including determining an electrical impedance between the first electrode and the second electrode.

[0011] In some embodiments, the operations further include determining a first electrical impedance based on the solution disposed within the lumen.

[0012] In some embodiments, determining the electrical impedance includes determining a change in the electrical impedance away from the first electrical impedance, wherein the change in the electrical impedance is caused by at least one of thrombus formation or bacterial adhesion within the lumen.

[0013] In some embodiments, the change in electrical impedance includes an increase in electrical impedance.

[0014] In some embodiments, the operations further include comparing the determined electrical impedance to an impedance limit stored in a memory, and providing a notification when the determined electrical impedance exceeds the impedance limit as a result of the comparison.

[0015] In some embodiments, the console includes a wireless module, and providing the notification includes wirelessly transmitting the notification to the external computing device.

[0016] In some embodiments, the first electrode receives an excitation voltage from a console, and the console receives a signal from the second electrode.

[0017] In some embodiments, at least a portion of each of the first electrode and the second electrode is embedded within the lumen wall.

[0018] In some embodiments, the system modules are arranged radially inward from an outer surface of the catheter tube.

[0019] In some embodiments, the system module is disposed proximal to the distal tip.

[0020] In some embodiments, the system modules are embedded within the lumen wall.

[0021] In some embodiments, the catheter system further comprises an auxiliary system comprising a light activated surface coating applied to the inner surface of the lumen wall, and the operation further comprises energizing a light source of the console to activate the surface coating, wherein activating the surface coating releases an agent configured to reduce the effects of at least one of thrombus formation or bacterial adhesion within the lumen. In some embodiments, the agent comprises at least one of an active pharmaceutical ingredient or an anticoagulant.

[0022] According to some embodiments, a method of a catheter system is also disclosed herein, comprising monitoring an electrical impedance between an electrode pair disposed within an inner cavity of a catheter of the catheter system. The catheter system comprises a system module having a console operatively coupled to the electrode pair, and wherein the system module is coupled to the catheter such that the system module is disposed within a patient during use. The method also comprises providing a notification when the electrical impedance exceeds a predefined impedance limit.

[0023] In some embodiments of the method, providing the notification includes wirelessly transmitting the notification to an external computing device.

[0024] In some embodiments of the method, the change in electrical impedance is caused by at least one of thrombus formation or bacterial adhesion within the lumen.

[0025] In some embodiments of the method, monitoring the electrical impedance includes: (i) determining a first electrical impedance based on a solution disposed within the lumen; and (ii) determining a change in the electrical impedance away from the first electrical impedance.

[0026] In some embodiments of the method, a system module of the catheter system is disposed within a patient.

[0027] In some embodiments of the method, the system module is embedded within the lumen wall of the catheter proximate the distal tip.

[0028] In some embodiments, the method further comprises energizing a light source of the system module to activate a surface coating applied to the inner lumen wall surface, wherein the activated surface coating releases an agent configured to reduce the effects of at least one of thrombus formation or bacterial adhesion within the lumen.

[0029] In some embodiments, the agent includes at least one of an active pharmaceutical ingredient or an anticoagulant.

[0030] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A catheter system according to some embodiments is shown.

[0032] Figure 2 According to some embodiments Figure 1 Detailed illustration of the distal portion of the catheter of the catheter system.

[0033] Figure 3 According to some embodiments Figure 1 A perspective view of a system module of a catheter system.

[0034] Figure 4A According to some embodiments Figure 1 Schematic diagram of a system module of a catheter system, which depicts a first use case.

[0035] Figure 4B According to some embodiments Figure 4A Schematic diagram depicting a second use case.

[0036] Figure 5 According to some embodiments Figure 3 A block diagram of the console of the system module.

[0037] Figure 6 According to some embodiments, Figure 1 A catheter system comprising: a catheter system further comprising an auxiliary system having a light-activated surface coating.

[0038] Figure 7 A block diagram of a method of a catheter system according to some embodiments is shown. DETAILED DESCRIPTION

[0039] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0040] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein.Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions.For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps.For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such labels are used to reflect, for example, relative position, orientation or direction.Singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly stipulates otherwise.

[0041] The phrases "connected to," "coupled to / coupled with," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be coupled to each other even if they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

[0042] The terms "proximal" and "distal" refer to the opposite ends of a medical device, including the devices disclosed herein. As used herein, the proximal portion of a medical device is the portion closest to a practitioner during use, while the distal portion is the portion at the opposite end. For example, the distal end of a catheter is defined as the end closest to a patient during use of the catheter, such as the distal end of the catheter. The proximal end is, for example, the end opposite the distal end, such as an extended leg of a catheter.

[0043] The term "logic" may refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term "logic" may refer to or include circuitry having data processing and / or storage capabilities. Examples of such circuitry may include, but are not limited to or restricted to, hardware processors (e.g., microprocessors, one or more processor cores, digital signal processors, programmable gate arrays, microcontrollers, application specific integrated circuits "ASICs", etc.), semiconductor memories, or combinational components.

[0044] Additionally or alternatively, the term "logic" may refer to or include software, such as one or more processes, one or more instances, an application programming interface (API), a subroutine, a function, an applet, a servlet, a routine, a source code, an object code, a shared library / dynamic link library (dll), or even one or more instructions. The software may be stored in any type of suitable non-transitory storage medium or transient storage medium (e.g., an electrical, optical, acoustic, or other form of propagating signal, such as a carrier wave, an infrared signal, or a digital signal). Examples of non-transitory storage media may include, but are not limited to or limited to: programmable circuits; non-persistent storage devices, such as volatile memory (e.g., any type of random access memory "RAM"); or persistent memory, such as non-volatile memory (e.g., read-only memory "ROM", power-powered RAM, flash memory, phase change memory, etc.), a solid-state drive, a hard drive, an optical drive, or a portable memory device. As firmware, the logic may be stored in a persistent storage device.

[0045] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0046] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchangeable with each other. In other words, unless the correct operation of the embodiment requires a specific order of steps or actions, the order and / or use of specific steps and / or actions can be modified. In addition, a subroutine or only a portion of the method described herein can be a separate method within the scope of the disclosed text. In other words, some methods can include only a portion of the steps described in the more detailed method. In addition, all embodiments disclosed herein are combinable and / or interchangeable, unless otherwise stated, or such combination or interchange will be contrary to the described operability of any embodiment.

[0047] Figure 1 A catheter system 100 is shown, which generally includes a catheter 110 and a system module 150 connected to the catheter 110 adjacent to a distal end 113. The catheter 110 can generally include any tubular device configured for, for example, placement in a patient, such as a central venous catheter (CVC), a peripherally inserted central catheter (PICC), a port infusion device, or a dialysis catheter. Such a catheter can be deployed together with auxiliary equipment and tubing (such as blood infusion equipment, plasma collection equipment, dialysis equipment, etc.) that contact blood. Foreign matter entering the lumen space of the catheter (such as bacterial adhesion or thrombosis) can affect the electrical impedance of the medium across / through the lumen space. This allows for appropriate impedance measurement signal changes that can be associated with bacterial adhesion or early thrombosis.

[0048] The system module 150 is typically configured to monitor the condition of the catheter 110, such as implicit monitoring of thrombosis and / or bacterial adhesion directly at the inner surface of the lumen of the catheter 110. This will allow clinicians to perform early detection and intervention to improve catheter functionality and clinical outcomes. The burden and reliance on external laboratory testing and hospital infrastructure will be reduced. In addition, the necessity of catheter removal and the complications of repeated catheter placement procedures can be alleviated. Monitoring at the direct site of infection and thrombosis will provide clinicians with information to provide better care and results to patients. In some embodiments, the system module 150 can be communicatively connected to an external computing device 50. In some embodiments, the external computing device can be, for example, a cellular phone or a tablet computer. In some embodiments, the external computing device 50 can be associated with a medical facility network or other auxiliary equipment.

[0049] The catheter 110 may include a catheter tubing 112 configured for insertion into a patient's body including a vascular system. The catheter tubing 112 extends between a hub 114 and a distal end 113. The catheter tubing 112 includes a plurality of (e.g., 1, 2, 3, or more) lumens extending along the catheter tubing 112, including a lumen 116. The catheter 110 also includes a plurality of extension legs 118 in fluid communication with the plurality of lumens. In some embodiments, the plurality of extension legs 118 may correspond to the plurality of lumens.

[0050] Figure 2 1 is a detailed cross-sectional view of a distal portion of the catheter tubing 112 adjacent the distal end 113. A system module 150 is shown operatively coupled to the lumen 116. In the illustrated embodiment, the system module 150 is embedded in the lumen wall 216 of the lumen 116. Thus, the system module 150 is configured for placement in a patient. The system module 150 can be arranged radially inward from the outer surface 212 of the catheter tubing 112 so that the system module 150 can not interfere with the placement of the catheter 110 in the patient. The method of manufacturing the catheter 110 can include insert molding the system module 150 into the lumen wall 216.

[0051] In the illustrated embodiment, the catheter system 100 includes a single system module 150 configured to monitor the condition of a single lumen. In other embodiments, the catheter system 100 may include more than one system module 150 to enable monitoring of more than one lumen. In a similar manner, the system module 150 may be configured to monitor the condition of more than one lumen.

[0052] Figure 3 The system module 150 is shown separated from the catheter tube 112. The system module 150 includes a first electrode 301 and a second electrode 302. The first electrode 301 and the second electrode 302 are configured to extend into the lumen 116 (see Figure 2 ), so that the first electrode 301 and the second electrode 302 can be electrically connected to the medium (e.g., liquid solution) in the inner cavity 116. The first electrode 301 and the second electrode 302 are spaced apart from each other. In some embodiments, the first electrode 301 and the second electrode 302 can be located on opposite sides of the inner cavity 116. The system module 150 may include a frame 320 to define the structure of the system module 150. In some embodiments, the frame 320 may include a printed circuit board. As shown in the figure, in some embodiments, the frame 320 may include a curved shape consistent with the curved shape of the inner cavity wall 216. The system module 150 includes a console 330 that can be accommodated in a housing 335, and the first electrode 301 and the second electrode 302 are operatively connected to the console 330. The system module 150 is generally configured to determine the electrical impedance between the first electrode 301 and the second electrode 302, as further described below.

[0053] FIG. 4A to FIG. 4B 1 is a schematic diagram of a system module 150 depicting determination of an electrical impedance between a first electrode 301 and a second electrode 302. In the illustrated embodiment, the electrical impedance may include a resistive component, a reactive component, and / or a combination thereof. A first electrode 301 and a second electrode 302 are shown electrically coupled to a console 330 and spaced apart from each other across an inner cavity 116. In the illustrated embodiment, the console 330 provides an excitation voltage 441 to the first electrode 301, and the console 330 receives an electrical signal from the second electrode 302, wherein the electrical signal is related to the impedance between the first electrode 301 and the second electrode 302.

[0054] Figure 4A For example, a situation is shown in which a solution 410 (e.g., saline) is disposed within the lumen 116, such as at the beginning of use of the catheter 110. In this case, a base or first impedance 431 is associated with the conductivity of the solution 410. In this case, the console 330 receives a first electrical signal 442 corresponding to the first impedance 431.

[0055] Figure 4B Another situation (e.g., a subsequent situation) is shown in which substance build-up 420 (such as bacterial adhesion or thrombosis) is present, for example, within lumen 116 together with solution 410. In some cases, substance build-up 420 can change the impedance between first electrode 301 and second electrode 302, thereby defining a second impedance 432 that is different from first impedance 431. In the example shown, second impedance 432 can be greater than first impedance 431. In this case, console 330 receives a second electrical signal 443 corresponding to second impedance 432.

[0056] Figure 5A block diagram of a console 330 according to some embodiments is shown. The console 330 is generally configured to manage the operation of the system module 150. The console 330 includes a processor 510 and a memory 520 (e.g., a non-transitory computer readable medium) having stored thereon monitor logic 521. The console 330 may include a wireless module 505 to facilitate wireless communication with an external computing device 50. In some embodiments, the wireless module 505 may be omitted.

[0057] The console 330 includes a voltage generator 531 configured to define and deliver the excitation voltage 441 to the first electrode 301. The signal conditioner 532 receives the electrical signal from the second electrode 302 and converts the electrical signal from the second electrode 302 into digital data for processing by the processor 510 according to the monitor logic 521.

[0058] The console 330 is powered via a power source 515. In some embodiments, the power source 515 can include an internal battery capable of providing sufficient power to operate the system module 150 throughout the life of the catheter system 100. Other power sources are also contemplated and therefore included herein. For example, the catheter system 100 can include an external power source coupled to the console 330. In such an embodiment, the catheter system 100 can include, for example, a conductive element extending along the catheter tubing 112, such as a wire embedded within the lumen wall 216. In some embodiments, one or more lumens containing a conductive solution can define one or more conductive elements that couple the external power source to the console 330.

[0059] In some embodiments, the console 330 can be disconnected from the power source 515 until the catheter system 100 is used. As an example, the second pair of electrodes can be disposed within the lumen (e.g., lumen 116), wherein the second pair of electrodes are included in the power circuit of the console 330. The second pair of electrodes are configured such that the absence of the conductive solution within the lumen defines the power circuit in an open state, which defines a deactivated state of the console 330. When the conductive solution is placed within the lumen, the conductive solution electrically couples the second pair of electrodes together to define the power circuit in a closed state, which defines an activated state of the console 330.

[0060] The monitor logic 521 generally defines the operation of the system module 150, including the exemplary operations described below. The monitor logic 521 determines the impedance between the first electrode 301 and the second electrode 302 based on the excitation voltage provided to the first electrode 301 and the electrical signal received from the second electrode 302. The monitor logic 521 can determine the first impedance 431, for example, during a situation in which the solution 410 is arranged in the lumen (such as before the catheter 110 is inserted into the patient's body). The monitor logic 521 can record and store the first impedance 431 in the memory 520. The monitor logic 521 can monitor the impedance between the first electrode 301 and the second electrode 302 during the use of the catheter 110 to detect the presence of material accumulation 420. In some embodiments, the monitor logic 521 can, for example, define an impedance limit, such as increasing a limited amount above the first impedance 431. Then, when the monitored impedance exceeds the impedance limit, the monitor logic 521 can provide a notification. In some embodiments, the monitor logic 521 can transmit the notification wirelessly to the external computing device 50.

[0061] In some embodiments, the system module 150 may be able to transition between a standby mode and an operating mode, wherein the standby mode may be configured to save battery life. In some embodiments, the monitor logic 521 may receive a wireless signal from the external computing device 50, and as a result of receiving the wireless signal, the monitor logic 521 may transition the system module 150 from the standby mode to the operating mode.

[0062] Figure 6 is a schematic diagram of a catheter system 100 that also includes an auxiliary system 600 according to some embodiments. In some embodiments, the auxiliary system 600 can be omitted. The auxiliary system 600 includes a coating 620 arranged on the inner surface of the inner cavity wall 216 adjacent to the distal end 113 along at least the distal portion of the catheter tube 112. The coating 620 is configured to transition from a passive state to an active state when exposed to light. In the illustrated embodiment, the auxiliary system 600 includes a plurality of (e.g., 1, 2, 3 or more) light sources 630, such as light emitting diodes (LEDs), for example, which are operatively connected to the console 330. Therefore, the monitor logic 521 can be configured to supply energy to the light source 630 and thereby activate the coating 620. In some embodiments, the monitor logic 521 can actively supply energy to the light source 630 as a means of detecting material accumulation 420 ( Figure 4B In some embodiments, the monitor logic 521 may energize the light source 630, for example, in response to an increase in the monitored impedance, such as when the monitored impedance exceeds a defined impedance limit.

[0063] The coating 620 is generally configured to reduce material accumulation 420 when activated. Figure 4B). In some embodiments, coating 620 can release a substance configured to denature (i.e., kill, destroy, remove, etc.) substance accumulation 420. For example, in some embodiments, coating 620 can release an active pharmaceutical agent. In other embodiments, coating 620 can release an anticoagulant.

[0064] Figure 7 A block diagram of a method 700 of a catheter system is shown, and according to some embodiments, the method may include all or any subset of the following steps, actions or processes. Method 700 includes monitoring the electrical impedance between an electrode pair disposed in the lumen of a catheter of the catheter system (block 710). The electrode pair is disposed adjacent to the distal end of the catheter. A change in the electrical impedance may be caused by thrombosis, bacterial adhesion, etc. in the lumen. Monitoring the electrical impedance may include: (i) determining a first electrical impedance based on a solution (e.g., saline) disposed in the lumen; and (ii) determining a change in the electrical impedance away from the first electrical impedance.

[0065] The method 700 may also include providing a notification when the electrical impedance exceeds the predefined impedance limit (block 720). Providing the notification may include wirelessly transmitting the notification to an external computing device.

[0066] The method 700 may also include energizing a light source of the system module to activate a surface coating (block 730), wherein the surface coating may be applied to an inner lumen wall surface of the catheter tubing. Activating the surface coating may release an agent configured to reduce the effects of at least one of thrombosis or bacterial adhesion within the lumen. The agent includes at least one of an active pharmaceutical ingredient or an anticoagulant.

[0067] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter system, characterized in that: include: A catheter, the catheter comprising: a catheter tube configured for placement within a patient; and a lumen wall defining a lumen extending along the catheter tube between the hub and the distal tip; and A system module is coupled to the catheter, the system module comprising: a first electrode and a second electrode, arranged in the inner cavity, for determining an electrical impedance between the first electrode and the second electrode, wherein: The first electrode and the second electrode are coupled to the lumen wall adjacent the distal tip, and the second electrode is spaced apart from the first electrode, The system module is configured to be placed in the patient's body.

2. The catheter system according to claim 1, characterized in that The system module includes a console configured to provide a notification when the determined electrical impedance exceeds an impedance limit.

3. The catheter system according to claim 2, characterized in that: The console includes a wireless module to wirelessly provide the notification to an external computing device.

4. The catheter system according to claim 1, characterized in that The system module includes a console coupled to the first electrode and the second electrode, The first electrode receives an excitation voltage from the console, and The console receives a signal from the second electrode.

5. The catheter system according to claim 1, characterized in that At least a portion of each of the first electrode and the second electrode is embedded within the lumen wall.

6. The catheter system according to claim 1, characterized in that The system modules are disposed radially inward from an outer surface of the catheter tube.

7. The catheter system according to any one of claims 1 to 5, characterized in that The system module is disposed adjacent the distal tip.

8. The catheter system according to any one of claims 1 to 5, characterized in that The system module is embedded in the inner cavity wall.

9. The catheter system according to claim 1, characterized in that Also included is an auxiliary system comprising a light-activated surface coating applied to an inner surface of the lumen wall, wherein a light source of a console of the system module is energized to activate the surface coating, wherein activation of the surface coating releases an agent configured to reduce the effects of at least one of thrombus formation or bacterial adhesion within the lumen.

10. The catheter system according to claim 9, characterized in that The agent includes at least one of an active pharmaceutical ingredient or an anticoagulant.

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